Needle-equipped outer tube

ABSTRACT

A needle-equipped outer tube includes a needle; a joint member that supports the needle, the needle being insert molded or thermally welded to the joint member; and an outer tube including a connection section, wherein the joint member is thermally welded to the connection section of the outer tube.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/260,965, filed on Apr. 24, 2014, which is a continuation applicationof and claims the benefit of priority from International PatentApplication No. PCT/JP2012/069545, filed on Aug. 1, 2012, which is basedupon and claims the benefit of priority of Japanese Application No.2011-241403 filed on Nov. 2, 2011. The contents of these applicationsare incorporated herein by reference in their entireties.

BACKGROUND Technical Field

The present disclosure relates to a method for manufacturing aneedle-equipped outer tube in which a needle of a syringe is directlyjoined to a distal end of an outer tube of the syringe in advance, andto the needle-equipped outer tube.

Background Art

Conventionally, in some outer tubes having a small volume used forinsulin administration or vaccination, a needle is previously joined tothe outer tube. Such a needle-equipped outer tube is manufactured byjoining the needle to the distal end of the outer tube with an epoxyadhesive, a UV-curing type adhesive, or the like (see, e.g., JapaneseExamined Utility Model Application Publication No. 1-11256 (hereinafter“JP '256”)). Further, there is a needle-equipped outer tube manufacturedby joining a needle to the distal end of the outer tube by insertmolding (see, e.g., PCT Publication No. WO 2008/139982 A (hereinafter“WO '982”)).

Besides the above, a prefilled syringe in which a medicine is previouslyfilled in the outer tube is frequently used. Further, a needle-equippedouter tube in which a medicine is previously filled is proposed.

However, in JP '256, in which a needle is joined to the distal end ofthe outer tube by an adhesive, the adhesive may make contact (liquidcontact) with a medicine which is previously filled in the outer tube ofthe needle-equipped outer tube, which may have a negative effect on themedicine. Therefore, there is a need for a technique to integrally forma needle and an outer tube with a novel joining method not using anadhesive.

Further, in WO '982, in which a needle is joined to the distal end ofthe outer tube by insert molding, a mechanism for arranging the needlein the cavity of the mold is necessary (e.g., a mechanism for insertingand removing a rod for attachment). Therefore, the molding machine andsupplementary equipment thereof needed to manufacture such a device arecomplex and large.

SUMMARY OF INVENTION

One object of the present invention is to provide a method formanufacturing a needle-equipped outer tube in which a needle is joinedto an outer tube with compact equipment and without using an adhesive,and a needle-equipped outer tube manufactured by the method formanufacturing a needle-equipped outer tube.

In one embodiment, a method for manufacturing a needle-equipped outertube is provided. A needle, a joint member having a needle insertionhole in which the needle can be inserted, and an outer tube providedwith a connection section at one of end portions in the axial directionare prepared. Further, the joint member, in which the needle is insertedin the needle insertion hole, engaging with the connection section ispressed toward the connection section by a pressing member, and underthis state, the needle and the joint member as well as the joint memberand the connection section are thermally welded to manufacture theneedle-equipped outer tube.

The method for manufacturing a needle-equipped outer tube includes, forexample, an engagement process, an assembling process, and a weldingprocess.

In the engagement process, the joint member engages with the connectionsection provided at one of end portions in the axial direction of theouter tube.

In the assembling process, the needle is inserted in the needleinsertion hole formed in the joint member.

In the welding process, the joint member is pressed along the axialdirection of the outer tube by the pressing member, and under thisstate, the joint member and the needle as well as the joint member andthe connection section are thermally welded.

In such method for manufacturing a needle-equipped outer tube, the jointmember and the needle as well as the joint member and the connectionsection of the outer tube are joined by thermal welding, so that theneedle is fixed to the outer tube without using an adhesive. Further,since the joint member is pressed along the axial direction of the outertube during the thermal welding, the thermal welding is carried out withno air existing between the joint member and the connection section ofthe outer tube. Consequently, foaming in the joint section (thermallywelded section) can be prevented, thereby preventing deterioration inaesthetic of the needle-equipped outer tube.

Further, the method for manufacturing a needle-equipped outer tube mayinclude, for example, an insert molding process, an engagement process,and a welding process.

In the insert molding process, the needle and the joint member whichsupports the needle are integrally formed by insert molding.

In the engagement process, the joint member supporting the needleengages with the connection section provided at the end portion in theaxial direction of the outer tube.

In the welding process, the joint member is pressed along the axialdirection of the outer tube by the pressing member, and under thisstate, the joint member and the connection section is thermally welded.

In the method for manufacturing a needle-equipped outer tube asdescribed above, the joint member supporting the needle is joined to theconnection section of the outer tube by thermal welding, so that theneedle can be fixed to the outer tube without using an adhesive.Further, since the joint member is pressed along the axial direction ofthe outer tube during the thermal welding, the joint member and theconnection section are thermally welded with no air existing between thejoint member and the connection section of the outer tube. Consequently,foaming in the joint section (thermally welded section) can beprevented, thereby preventing deterioration in the appearance of theneedle-equipped outer tube.

The needle-equipped outer tube according to an embodiment of the presentinvention includes the needle, the joint member supporting the needle,and the outer tube.

The outer tube includes the connection section which engages with, andis joined to, the joint member.

Further, the joint member engaging with the connection section of theouter tube is pressed along the axial direction of the outer tube, andunder this state, the joint member is joined to the connection sectionby thermal welding.

The needle and the joint member of the needle-equipped outer tube arejoined by thermal welding or insert molding. Further, since the jointmember and the connection section of the outer tube are joined bythermal welding, the needle is fixed to the outer tube without using anadhesive.

The method for manufacturing a needle-equipped outer tube and theneedle-equipped outer tube provide high joint strength withoutdeteriorating the appearance since the boundary surface between thejoint member and the connection section becomes uniform and transparent.Further, since the joint member is pressed toward the connection sectionduring the joining process, the air existing between the joint memberwhich is heat melted and the connection section is discharged from thespace between the joint member and the connection section. Further, bysuitably setting the heating temperature, foaming in the joint memberand the connection section (resin) is prevented. As a result, problemssuch as reduced strength, contamination, and permeation of a medicinecaused by the air existing between the joint member and the connectionsection can be prevented. Further, since the joint member can be maderelatively small, equipment for insert molding the needle and the jointmember can be downsized.

By the method for manufacturing a needle-equipped outer tube and theneedle-equipped outer tube according to embodiments of the presentinvention, the needle can be joined to the outer tube with compactequipment without using an adhesive.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a needle-equipped outer tube accordingto a first embodiment.

FIG. 2 is an exploded perspective view of the needle-equipped outer tubeof the first embodiment.

FIG. 3 is a perspective view illustrating a state in which a cap isattached to the needle-equipped outer tube of the first embodiment.

FIG. 4 is a cross sectional view of the needle-equipped outer tube andthe cap illustrated in FIG. 3.

FIG. 5 is an explanatory drawing explaining a method for manufacturingthe needle-equipped outer tube of the first embodiment.

FIG. 6 is a cross sectional view illustrating a needle stopping portionof the needle-equipped outer tube of the first embodiment.

FIG. 7 is a cross sectional view illustrating a needle supportingportion used in the method for manufacturing a needle-equipped outertube.

FIG. 8 is a perspective view of a needle-equipped outer tube accordingto a second embodiment.

FIG. 9 is an exploded perspective view of needle-equipped outer tube ofthe second embodiment.

FIG. 10 is an explanatory drawing explaining a method for manufacturingthe needle-equipped outer tube of the second embodiment.

FIG. 11 is an explanatory drawing of a needle-equipped outer tubeaccording to a third embodiment.

FIG. 12 is an explanatory drawing of a needle-equipped outer tubeaccording to a fourth embodiment.

FIG. 13 is an explanatory drawing of a needle-equipped outer tubeaccording to a fifth embodiment.

FIG. 14 is an explanatory drawing of a needle-equipped outer tubeaccording to a sixth embodiment.

FIG. 15 is an explanatory drawing of a needle-equipped outer tubeaccording to a seventh embodiment.

DETAILED DESCRIPTION

The needle-equipped outer tube according to embodiments of the presentinvention will be described below referring to FIG. 1 to FIG. 15. Notethat, in each of the drawings, the same component is indicated with thesame reference numeral. Further, the present invention is not limited tothe embodiments described below.

Note that, the description will be made in the order listed below.

-   -   1. First embodiment of the needle-equipped outer tube        -   Configuration of a needle-equipped outer tube        -   Method for manufacturing a needle-equipped outer tube    -   2. Second embodiment of the needle-equipped outer tube        -   Configuration of a needle-equipped outer tube        -   Method for manufacturing a needle-equipped outer tube    -   3. Third embodiment of the needle-equipped outer tube    -   4. Fourth embodiment of the needle-equipped outer tube    -   5. Fifth embodiment of the needle-equipped outer tube    -   6. Sixth embodiment of the needle-equipped outer tube    -   7. Seventh embodiment of the needle-equipped outer tube

1. First Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

First, the configuration of the first embodiment of the needle-equippedouter tube will be described referring to FIG. 1 and FIG. 2.

FIG. 1 is a perspective view of the first embodiment of theneedle-equipped outer tube. FIG. 2 is an exploded perspective view ofthe first embodiment of the needle-equipped outer tube.

The needle-equipped outer tube 1 is used to carry out piercing from thesurface of a skin with a needle tip so as to inject a medicine into aliving body. As illustrated in FIG. 1, the needle-equipped outer tube 1includes a needle 2, a joint member 3 to which the needle 2 is joined,and an outer tube 4 to which the joint member 3 is joined. Further, acap 5 (see FIG. 3 and FIG. 4) is attached to the needle-equipped outertube 1.

[Needle]

First, the needle 2 will be described.

A needle having a gauge size of 10 to 33 (outer diameter of ϕ 3.5 to 0.2mm) according to ISO standards for medical needles (ISO9626:1991/Amd.1:2001(E)) is used as the needle 2. Preferably, a needle having a gaugesize of 16 to 33 (outer diameter of ϕ 1.7 to 0.2 mm) is used.

At one of the ends (in the axial direction) of the needle 2, a needletip 2 a which is pierced into a living body is provided. The needle tip2 a has a sharp acute angle forming a bladed edge. Hereinafter, theother end of the needle 2, that is, the end on the side opposite theneedle tip 2 a, will be referred to as the “proximal end” 2 b (see FIG.2). The needle tip 2 a of the needle 2 protrudes from a distal endsurface 11 a of the joint member 3. The proximal end 2 b of the needle 2protrudes from a rear end surface 12 a of the joint member 3. Theproximal end 2 b of the needle 2 is arranged in a connection section 16of the outer tube 4.

The middle portion of the needle 2 is inserted in a tubular hole 3 a ofthe joint member 3. The surface of the middle portion of the needle 2 isformed to have a rough surface by applying blasting or the like. In thismanner, when the needle 2 and the joint member 3 are joined by thermalwelding, the joint strength between the needle 2 and the joint member 3can be improved by the softened (melted) resin making tight contact withthe rough surface of the needle 2. Further, by the softened (melted)resin making tight contact with the rough surface of the needle 2, fluidtightness can be improved. Note that, the surface of the needle 2 may befinished to have a roughness (Ra) of 1.0 to 3.0, preferably, 1.3 to 2.0,by blasting or the like.

As a material of the needle 2, for example, a stainless steel may beused. However, the material is not limited to a stainless steel.Aluminum, an aluminum alloy, titanium, a titanium alloy, or other metalsmay be used. Further, as for the needle 2, not only a straight needlebut also a tapered needle in which at least a portion is tapered can beused. The tapered needle may have a proximal end portion having adiameter larger than that of the end portion of the needle tip 2 a, anda middle portion configured as a tapered structure. Further, the crosssectional shape of the needle 2 is not limited to a circle, and may alsobe a polygon such as a triangle.

Further, to the portion of the surface of the needle 2 close to theneedle tip 2 a, a coating material composed of, for example, a siliconeresin, a fluorine-based resin, or the like is applied. In this manner,the friction between the skin and the needle 2 produced when the needle2 is pierced into a living body can be reduced, which can ease a painduring the piercing.

[Joint Member]

Now, the joint member 3 will be described.

As illustrated in FIG. 2, the joint member 3 is formed in anapproximately cylindrical shape having a tubular hole (needle insertionhole) 3 a in which the needle 2 is inserted. The diameter of the tubularhole 3 a is provided to be larger than the outer diameter of the needle2 by about 0.01 to 0.08 mm, preferably, by about 0.01 to 0.03 mm.

The joint member 3 is configured with a distal end side tubular portion11 and a rear end side tubular portion 12 having an outer diametersmaller than that of the distal end side tubular portion 11.

The distal end side tubular portion 11 is formed in a cylindrical shapehaving a uniform outer diameter. On the end portion of the distal endside tubular portion 11, opposite to the rear end side tubular portion12, a distal end surface 11 a is formed. The distal end surface 11 a isa press force receiving surface which is pressed by a pressing portion101 a of a pressing apparatus 101 which will be described below.

On the end portion of the rear end side tubular portion 12, opposite tothe distal end side tubular portion 11, a rear end surface 12 a isformed. The rear end side tubular portion 12 is formed in a taperedshape in which the outer diameter gradually decreases toward the rearend surface 12 a.

As a material of the joint member 3, various types of resin such aspolyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin,polystyrene, poly(4-methylpentene-1), polycarbonate, acrylic resin,acrylonitrile-butadiene-styrene copolymer, polyester such aspolyethylene-telephthalate, butadiene-styrene copolymer, and polyamide(e.g., nylon 6, nylon 6,6, nylon 6,10, nylon 12) may be used. Amongthose, a resin such as polypropylene, cyclic polyolefin, polyester, andpoly(4-methylpentene-1) is preferably used. Note that, it is preferablethat the material of the joint member 3 is substantially transparent sothat the inside of the joint member 3 is visible.

[Outer Tube]

Now, the outer tube 4 will be described.

The outer tube 4 includes an outer tube body 15 in which a medicine isfilled and a connection section 16 to which the joint member 3 isjoined. The outer tube body 15 is formed in an approximately cylindricalshape having a tubular hole 15 a (see FIG. 4). The connection section 16is provided at an end portion 15 b in the axial direction of the outertube body 15 and a flange 17 is formed on the other end portion 15 c.

When the needle-equipped outer tube 1 is used as an ordinary syringe, apusher and a gasket (not shown in the drawing) are inserted from theother end portion 15 c side of the outer tube body 15. Further, when theneedle-equipped outer tube 1 is used as a prefilled outer tube, a pusherand a gasket are inserted from the other end portion 15 c side after amedicine is filled in the tubular hole 15 a of the outer tube body 15.

A medicine to be filled in the tubular hole 15 a of the outer tube body15 may be any medicine which is usually used as an injection, forexample, a protein drug such as an antibody, a peptide pharmaceuticalsuch as a hormone, a nucleic acid medicine, a cellular medicine, a bloodproduct, a vaccine for preventing infections, an anticancer agent, ananesthetic, a drug, an antibiotic, a steroid, a proteolytic enzymeinhibitor, a heparin, a saccharide injection such as a glucose, aninjection for correcting electrolyte imbalance such as sodium chlorideand potassium lactate, a vitamin compound, a fat emulsion, a contrastmedia, and a stimulant.

Note that, in the embodiment, description is made for an example inwhich the shape of the outer tube body 15 is formed in an approximatelycylindrical shape, though the shape of the outer tube body 15 may be ahollow quadrangular prism shape or a hexagonal prism shape.

The connection section 16 is configured with a tapered engagementportion 18 which is continued to the end portion 15 b of the outer tubebody 15 and a distal end side engagement portion 19 which is continuedto the tapered engagement portion 18.

The tapered engagement portion 18 has an approximately cross-shapedcross section in a plane perpendicular to the axial direction of theouter tube 4, and an engagement hole 18 a having a circular crosssection (see FIG. 4 and FIG. 5). The engagement hole 18 a is formed in atapered shape (tapered inner shape) in which the diameter graduallydecreases toward the end portion 15 b of the outer tube body 15. Therear end side tubular portion 12 of the joint member 3 is inserted inthe engagement hole 18 a.

The rear end side tubular portion 12 is formed in a tapered shape(tapered outer shape) so as to engage with the engagement hole 18 a.Further, taper angles of the engagement hole 18 a and the rear end sidetubular portion 12 are not particularly limited, though an angle of 1 to3 degrees is preferable.

The distal end side engagement portion 19 has an approximately circularcross section in a plane perpendicular to the axial direction of theouter tube 4, and an engagement hole 19 a (see FIG. 3). The distal endside tubular portion 11 of the joint member 3 is inserted in theengagement hole 19 a. Note that, the diameter of the engagement hole 19a is approximately the same as the outer diameter of the distal end sidetubular portion 11 of the joint member 3.

As a material of the outer tube 4 configured with the connection section16 and the outer tube body 15, a resin similar to that used for thejoint member 3 is preferably used. Note that, it is preferable that thematerial of the outer tube 4 is substantially transparent so that theinside of the outer tube 4 is visible.

Further, the connection section 16 of the outer tube 4 and the jointmember 3 are joined by thermal welding. Therefore, it is preferable thatthe material of the outer tube 4 is substantially the same as thematerial of the joint member 3. In this manner, preferable bondabilitybetween the connection section 16 and the joint member 3 can be obtainedso that the connection section 16 and the joint member 3 can firmly befixed. Further, the welded portion between the connection section 16 andthe joint member 3 can be made inconspicuous so that aesthetic of theneedle-equipped outer tube 1 can be improved.

[Cap]

Now the cap 5 will be described referring to FIG. 3 and FIG. 4.

FIG. 3 is a perspective view illustrating a state in which the cap 5 isattached to the needle-equipped outer tube 1. FIG. 4 is a crosssectional view illustrating the needle-equipped outer tube 1 and the cap5 illustrated in FIG. 3.

As illustrated in FIG. 3 and FIG. 4, the cap 5 is formed in anapproximately cylindrical shape with one end in the axial directionopened and the other end in the axial direction closed. The cap 5 isformed of a flexible member, for example, a rubber or an elastomer.

The cap 5 is attached to the connection section 16 of the outer tube 4so as to cover the needle tip 2 a of the needle 2 and the connectionsection 16 of the outer tube 4. Further, as illustrated in FIG. 4, aportion of the needle 2 in the needle tip 2 a side and the connectionsection 16 are inserted into the tubular hole 5 a of the cap 5.

Note that, the inner diameter of the tubular hole 5 a of the cap 5 isprovided to be approximately the same as, or slightly smaller than, theouter diameter of the distal end side engagement portion 19 of theconnection section 16. Therefore, when the cap 5 is attached to theconnection section 16, the outer circumferential surface of the distalend side engagement portion 19 makes tight contact with the innercircumferential surface of the cap 5. In this manner, the space aroundthe needle 2 protruding from the joint member 3 is sealed by the distalend side engagement portion 19 and the inner circumferential surface ofthe cap 5. As a result, adhering of germs to the needle tip 2 a can beprevented.

Further, the inner circumferential surface of the cap 5 compresses theboundary portion (narrow portion) between the distal end side engagementportion 19 and the tapered engagement portion 18 of the connectionsection 16 by the elastic force of the cap 5. In this manner, the innercircumferential surface of the cap 5 and the narrow portion of theconnection section 16 engage with each other, thereby preventing the cap5 from coming off from the connection section 16 (outer tube 4) duringtransportation.

<Method for Manufacturing a Needle-Equipped Outer Tube>

Now, a method for manufacturing the needle-equipped outer tube 1 will bedescribed referring to FIG. 5 and FIG. 6.

FIG. 5 is an explanatory drawing explaining the method for manufacturingthe needle-equipped outer tube 1. FIG. 6 is a cross sectional viewillustrating a needle stopping portion of the needle-equipped outer tube1.

When manufacturing the needle-equipped outer tube 1, at first, each ofthe needle 2, the joint member 3 and the outer tube 4 is prepared. Theneedle 2 is formed in a desired tubular body by, for example, pressworking of a metal plate or swaging process of a hollow pipe. Each ofthe joint member 3 and the outer tube 4 is formed by injection molding.By separately forming the joint member 3 and the outer tube 4 in thismanner, a mold can be made small and simple.

[Engagement Process]

Next, an engagement process is carried out. In the engagement process,the joint member 3 is inserted into the engagement holes 18 a and 19 aof the connection section 16 of the outer tube 4. In this manner, therear end side tubular portion 12 of the joint member 3 engages with thetapered engagement portion 18 of the connection section 16, and at thesame time, the distal end side tubular portion 11 of the joint member 3engages with the distal end side engagement portion 19 of the connectionsection 16.

[Assembling Process]

Next, the assembling process will be carried out. In the assemblingprocess, the needle 2 is inserted in the tubular hole 3 a of the jointmember 3. In the process, the proximal end 2 b of the needle 2 makescontact with a needle stopping portion 21 provided in the connectionsection 16 of the outer tube 4 (see FIG. 6). In this manner, the needle2 is positioned against the joint member 3 and the outer tube 4 and theproximal end 2 b of the needle 2 is arranged in the connection section16. In other words, the proximal end 2 b of the needle 2 is not arrangedin the tubular hole 15 a of the outer tube body 15. Consequently, thedead volume in the outer tube 4 can be reduced, thereby reducing theamount of medicine remaining in the outer tube 4.

As illustrated in FIG. 6, the needle stopping portion 21 is formed in aring shaped protrusion which protrudes from the inner surface of thetapered engagement portion 18. A communication hole 21 a provided in thecenter of the needle stopping portion 21 makes communication between thetubular hole 15 a of the outer tube body 15 and engagement holes 18 aand 19 a of the connection section 16. Therefore, a needle hole of theneedle 2 which is positioned by making contact with the needle stoppingportion 21 communicates with the tubular hole 15 a of the outer tubebody 15 via the communication hole 21 a.

For example, when a 27G needle is applied as the needle 2, the outerdiameter of the needle 2 is ϕ 0.41 mm and the inner diameter is ϕ 0.19to 0.25 mm. In this case, the diameter of the communication hole 21 a ofthe needle stopping portion 21 is preferably be ϕ 0.26 to 0.4 mm.

[Welding Process]

Next, a welding process is carried out. In the welding process, thedistal end surface 11 a of the joint member 3 is pressed along the axialdirection of the outer tube 4 by the pressing apparatus 101, and underthis state, the joint member 3 and the needle 2 as well as the jointmember 3 and the connection section 16 of the outer tube 4 are joined bythermal welding.

The pressing apparatus 101 includes a pressing portion 101 a whichpresses the distal end surface 11 a of the joint member 3. By applyingpressure to the joint member 3 by the pressing portion 101 a, the outercircumferential surface of the rear end side tubular portion 12 and theinner circumferential surface of the tapered engagement portion 18 canbe kept in tight contact with each other.

In the embodiment, the thermal welding is carried out using a highfrequency induction heating apparatus 110. The high frequency inductionheating apparatus 110 includes a work coil 111 and a power source 112which supplies an AC current to the work coil 111.

When the power source 112 supplies an AC current to the work coil 111, amagnetic field is generated around the work coil 111 and an eddy currentis produced in the needle 2. Therefore, the temperature of the needle 2rises to heat the joint member 3. Then the joint member 3 softens toadhere to the needle 2 and the connection section 16 of the outer tube4. As a result, the joint member 3 and the needle 2 as well as the jointmember 3 and the connection section 16 of the outer tube 4 are joined bythermal welding and thereby, the needle-equipped outer tube 1 ismanufactured.

Note that, when the thickness of the joint member 3 is provided to be0.4 to 0.55 mm, it is preferable to set the output of the power source112 to be 46 to 52 V with 2.5 to 3.2 A and the oscillation period of thework coil 111 to be 4 to 10 seconds (s). Further, the pressing forceapplied to the joint member 3 is preferably set to be 50 to 100 N.

The condition mentioned above is the case where cyclic olefin polymer(COP) being cyclic polyolefin is used as the material of the jointmember, though a condition should be determined to give a suitable resintemperature according to the characteristic of the resin to be used, soas to prevent occurring of foaming, a burnt resin, and deformation.

In the embodiment, since the joint member 3 and the needle 2 as well asthe joint member 3 and the outer tube 4 are joined using the highfrequency induction heating apparatus 110, the needle 2 is fixed to theouter tube 4 without using an adhesive.

Further, in the embodiment, since the thermal welding is carried outwith the joint member 3 pressed along the axial direction of the outertube 4 by the pressing apparatus 101, no gap is produced between thejoint member 3 and the connection section 16 of the outer tube 4. Inthis manner, foaming will not occur in the joint member 3 when the jointmember 3 is heated. As a result, transparency is provided to the jointsection without deteriorating aesthetic, and at the same time, the jointmember 3 and the needle 2 as well as the joint member 3 and theconnection section 16 of the outer tube 4 can tightly be fixed.

Further, since the surface of the portion, inserted in the joint member3, of the needle 2 is formed in a rough surface by blasting or the like,the softened resin (joint member 3) makes tight contact with the roughsurface of the needle 2. As a result, joint strength as well as fluidtightness between the needle 2 and the joint member 3 can be improved.

Further, since the insert molding is not used in the embodiment, acomplex and large insert molding apparatus is not necessary so that anexcellent needle-equipped outer tube can be manufactured with low cost.

[Comparative Experiment]

Now, the description will be made for a comparative experiment in whichcases with and without pressing of the joint member 3 in the weldingprocess using the high frequency induction heating apparatus 110 arecompared.

The work coil 111 having an average wire diameter of ϕ 4.3 mm and anaverage coil inner diameter of ϕ 9 mm is used. The power source 112 isset to output 5 kW with 2 MHz. Further, the work coil is positioned inthe middle of the joining section, specifically, in a location 5 to 6 mmfrom the distal end (distal end side engagement portion 19 side) of theconnection section 16. The needle 2 of 27G is used and the thickness ofthe joint member 3 is provided to be 0.47 mm. Further, taper angles ofthe engagement hole 18 a and the rear end side tubular portion 12 areprovided to be 1.6 degrees.

The experiment is evaluated by “external appearance” and “jointstrength”. The “external appearance” is evaluated to be good (◯) whenthere is no foaming or burning and the length of the welded section is 2mm or more. Further, “joint strength” is expressed by force (N) requiredto remove the joint member 3 from the connection section 16 of the outertube 4. It is sufficient to have the “joint strength” of 50 N or higher,preferably, 80 to 120 N.

The result of the comparative experiment is shown in Table 1.

TABLE 1 Welding condition Result of welding High frequency outputWelding External Joint Voltage Current Time pressure appear- strength(V) (A) (sec) (N) ance (N) Example 1 52 3.2 4 60 ◯ 110 Example 2 46 2.510 60 ◯ 110 Comparative 52 3.2 4 0 X 50 example 1 (Foaming)

As shown in Table 1, evaluations of “external appearance” for Example 1and Example 2 which include pressing of the joint member 3 are good (◯).And “joint strength” is 110 N.

Contrarily, for Comparative example 1 which doesn't include pressing ofthe joint member 3, the evaluation of “external appearance” is not good(x) since foaming occurred in the welded portion. And “joint strength”is 50 N.

According to the comparative experiment, the case in which thermalwelding is carried out with the joint member 3 pressed resulted inbetter “external appearance” and higher “joint strength” than the casein which the joint member 3 is not pressed. Note that, it can beunderstood that in Comparative example 1, the foaming occurred in thewelded portion resulting in reduction of the length of the weldedportion to be less than 2 mm, thereby reducing “joint strength”.

[Exemplary Modification]

As illustrated in FIG. 6, in the embodiment, the proximal end 2 b of theneedle 2 is made to contact the needle stopping portion 21 of the outertube 4 to position the needle 2 during the assembling process. However,the positioning of the needle 2 is not limited to the manner using theneedle stopping portion 21, and may be carried out by, for example, amember other than the needle-equipped outer tube 1.

FIG. 7 is a cross sectional view illustrating a needle supporting memberused in the method for manufacturing a needle-equipped outer tube of thepresent invention.

As illustrated in FIG. 7, the needle supporting member 102 includes abase portion 102 a arranged in the tubular hole 15 a of the outer tubebody 15 and a support protrusion 102 b which protrudes from the upperend of the base portion 102 a and supports the proximal end 2 b of theneedle 2.

The support protrusion 102 b of the needle supporting member 102 isinserted in the engagement hole 18 a of the connection section 16.Therefore, the proximal end 2 b of the needle 2 supported by the supportprotrusion 102 b is arranged in the connection section 16. In otherwords, the needle 2 is not arranged in the tubular hole 15 a of theouter tube body 15. Consequently, the dead volume in the outer tube 4can be reduced, thereby reducing the amount of medicine remaining in theouter tube 4.

Further, as for an exemplary modification for minimizing the deadvolume, the distal end of the needle supporting member 102 may be formedflat so as to block the engagement hole 18 a of the connection section18.

2. Second Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Now, the second embodiment of the needle-equipped outer tube will bedescribed referring to FIG. 8 and FIG. 9.

FIG. 8 is a perspective view of the second embodiment of theneedle-equipped outer tube. FIG. 9 is an exploded perspective view ofthe second embodiment of the needle-equipped outer tube.

A needle-equipped outer tube 31 has a configuration similar to that ofthe needle-equipped outer tube 1 of the first embodiment (see FIG. 1).The needle-equipped outer tube 31 is different from the needle-equippedouter tube 1 in that the needle 2 and the joint member 3 are integrallyformed in advance by insert molding, and in the shape of an outer tube34.

As illustrated in FIG. 8 and FIG. 9, the needle-equipped outer tube 31includes a needle block 32 and the outer tube 34 to which the needleblock 32 is joined. Further, the cap 5 (see FIG. 3 and FIG. 4) isattached to the needle-equipped outer tube 31.

[Needle Block]

Now, the needle block 32 will be described.

The needle block 32 includes the needle 2 and the joint member 3 whichsupports the needle 2. The needle 2 and the joint member 3 areintegrally formed by insert molding.

The needle tip 2 a of the needle 2 of the needle block 32 protrudes fromthe distal end surface 11 a of the joint member 3, and the proximal end2 b of the needle 2 protrudes from the rear end surface 12 a of thejoint member 3 and is arranged in a connection section 46, which will bedescribed below, of the outer tube 34. The distance from the rear endsurface 12 a of the joint member 3 to the proximal end 2 b of the needle2 is determined so as the proximal end 2 b of the needle 2 not to beinserted in the tubular hole 15 a (see FIG. 10) of the outer tube body15 of the outer tube 34.

[Outer Tube]

Next, the outer tube 34 will be described.

The outer tube 34 includes the outer tube body 15 in which a medicine isfilled and the connection section 46 to which the joint member 3 of theneedle block 32 is joined.

The connection section 46 is configured with a tapered engagementportion 48 which is continued to the end portion 15 b of the outer tubebody 15 and the distal end side engagement portion 19 which is continuedto the tapered engagement portion 48.

The tapered engagement portion 48 is formed in a truncated conicalshape. The diameter of the tapered engagement portion 48 graduallydecreases toward the distal end side engagement portion 19. Therefore,the tapered engagement portion 48 is formed so as that the cross sectionperpendicular to the axial direction of the outer tube 34 is a nearcircle.

Further, the tapered engagement portion 48 includes an engagement hole48 a which communicates with the engagement hole 19 a of the distal endside engagement portion 19. The engagement hole 48 a is formed in atapered shape (tapered inner shape) in which the diameter graduallydecreases toward the end portion 15 b of the outer tube body 15. Therear end side tubular portion 12 of the joint member 3 is inserted inthe engagement hole 48 a.

The rear end side tubular portion 12 is formed in a tapered shape(tapered outer shape) so as to engage with the engagement hole 48 a.Further, taper angles of the engagement hole 48 a and the rear end sidetubular portion 12 are not particularly limited, though angle of 1 to 3degrees is preferable.

Conventionally, a connection section of an outer tube and a needle areintegrally formed by insert molding. In a case of carrying out injectionmolding (insert molding), a shrink mark is likely to occur in a thickregion. Therefore, when the connection section of the outer tube and theneedle are integrally formed by insert molding, the cross section ismade, for example, in a cross-shape, so as to restrain the thickness ofthe connection section.

However, in the needle-equipped outer tube according to the presentinvention, the portion which supports the needle is formed by joiningthe connection section of the outer tube and a joint member providedseparately from the connection section. Therefore, the thickness of thetapered engagement portion 48 of the connection section 46 of theembodiment of the present invention is restrained even when the taperedengagement portion 48 has a conical shape (column shape). Consequently,even when the tapered engagement portion 48 has a conical shape (columnshape), generation of a shrink mark can be prevented or restrained.

In the embodiment, the cap 5 (see FIG. 4) can be made to tightly contactthe tapered engagement portion 48 since the tapered engagement portion48 is provided in a conical shape (column shape). As a result,sealability in the cap 5 can be provided so that the inside of the cap 5can be kept clean. Further, the cap 5 is further securely assembled,since the cap 5 (see FIG. 4) tightly contacts the tapered engagementportion 48.

<Method for Manufacturing a Needle-Equipped Outer Tube>

Next, the method for manufacturing the needle-equipped outer tube 31will be described referring to FIG. 10.

FIG. 10 is an explanatory drawing explaining the method formanufacturing the needle-equipped outer tube 1.

When the needle-equipped outer tube 31 is manufactured, firstly, theneedle 2 and the outer tube 34 are prepared. The needle 2 is formed in adesired tubular body by, for example, press working of a metal plate orswaging process of a hollow pipe. The outer tube 34 is formed by, forexample, injection molding.

[Insert Molding Process]

Next, the insert molding process will be described. In the insertmolding process, the needle 2 and the joint member 3 are integrallyformed by insert molding. Thereby, the needle block 32 is manufactured.Since the needle block 32 and the outer tube 34 are separately molded inthis manner, a mold and a molding apparatus can be downsized.

[Engagement Process]

Next, an engagement process is carried out. In the engagement process,the joint member 3 of the needle block 32 is inserted in the engagementholes 48 a and 19 a of the connection section 46 of the outer tube 4. Inthis manner, the rear end side tubular portion 12 of the joint member 3engages with the tapered engagement portion 48 of the connection section46 and at the same time, the distal end side tubular portion 11 of thejoint member 3 engages with the distal end side engagement portion 19 ofthe connection section 46.

Thereby, the needle 2 of the needle block 32 is positioned against theouter tube 34 and the proximal end 2 b of the needle 2 is arranged inthe connection section 46. In other words, the proximal end 2 b of theneedle 2 is not arranged in the tubular hole 15 a of the outer tube body15. As a result, the dead volume in the outer tube 34 can be reduced,thereby reducing the amount of medicine remaining in the outer tube 34.

[Welding Process]

Next, a welding process is carried out. In the welding process, thedistal end surface 11 a of the joint member 3 is pressed along the axialdirection of the outer tube 34 by the pressing apparatus 101, and underthis state, the joint member 3 of the needle block 32 and the connectionsection 16 of the outer tube 34 are joined by thermal welding.

By applying pressure to the joint member 3 by the pressing portion 101 aof the pressing apparatus 101, the outer circumferential surface of therear end side tubular portion 12 and the inner circumferential surfaceof the tapered engagement portion 48 can be kept in tight contact witheach other.

In the embodiment, a semiconductor laser irradiation apparatus 120 isused to carry out thermal welding. The joint section of the needle 2 ofthe needle block 32 is irradiated with a laser by the semiconductorlaser irradiation apparatus 120. Therefore, the temperature of theneedle 2 rises to heat the joint member 3. Then, the joint member 3softens to adhere to the needle 2 and the connection section 46 of theouter tube 34. As a result, the joint member 3 and the needle 2 as wellas the joint member 3 and the connection section 46 of the outer tube 34are joined by thermal welding and thereby, the needle-equipped outertube 31 is manufactured.

Note that, when the thickness of the joint member 3 is provided to be0.4 to 0.55 mm, it is preferable to set the output of the semiconductorlaser irradiation apparatus 120 to be 15 to 25 W and the irradiationtime of a laser to be 1.5 to 3 seconds (s). Further, as for an opticalsystem, a focus diameter is preferably set to be ϕ 2.5 to 4 mm. Further,the pressing force applied to the joint member 3 is preferably set to be50 to 100 N.

The condition mentioned above is the case where cyclic olefin polymer(COP) being cyclic polyolefin is used as the material of the jointmember, though a condition should be determined to give a suitable resintemperature according to the characteristic of the resin to be used, soas to prevent occurring of foaming, a burnt resin, and deformation.

In the embodiment, since the joint member 3 and the needle 2 as well asthe joint member 3 and the outer tube 34 are joined by using thesemiconductor laser irradiation apparatus 120, the needle 2 is fixed tothe outer tube 34 without using an adhesive.

Further, in the embodiment, since the thermal welding is carried outwith the joint member 3 pressed along the axial direction of the outertube 34 by the pressing apparatus 101, no gap is produced between thejoint member 3 and the connection section 46 of the outer tube 34. Inthis manner, foaming will not occur in the joint member 3 when the jointmember 3 is heated. As a result, transparency is provided to the jointsection without deteriorating aesthetic, and at the same time, the jointmember 3 and the needle 2 as well as the joint member 3 and theconnection section 46 of the outer tube 34 can tightly be fixed.

Further, regarding the injection molding of the outer tube, since thepiece formed by injection molding is far smaller than the piece made bydirectly forming the needle on the outer tube by insert molding, themolding apparatus can be downsized, thereby reducing the cost offacility.

[Comparative Experiment]

Next, the description will be made for a comparative experiment in whichcases with and without pressing of the joint member 3 in the weldingprocess using the semiconductor laser irradiation apparatus 120 arecompared.

The output of the semiconductor laser irradiation apparatus 120 is setto be 15 W or 20 W. The irradiation time of a laser is set to be 1.5 to3 seconds. Further, the focus diameter of the semiconductor laserirradiation apparatus 120 is set to be ϕ 3 mm for every case. Thelocation which is irradiated with a laser is set in the middle of thejoint section, specifically, 5 to 6 mm from the distal end (distal endside engagement portion 19 side) of the connection section 16. Theneedle 2 of 27G is used and the thickness of the joint member 3 isprovided to be 0.47 mm.

The experiment is evaluated by “external appearance” and “jointstrength”. The “external appearance” is evaluated to be good (◯) whenthere is no foaming or burning and the length of the welded section is 2mm or more. Further, “joint strength” is expressed by force (N) requiredto remove the joint member 3 from the connection section 46 of the outertube 34. It is sufficient to have the “joint strength” of 50 N orhigher, preferably, 80 to 120 N.

The result of the comparative experiment is illustrated in Table 2.

TABLE 2 Welding condition Laser output Welding Result of welding EnergyTime pressure External Joint (W) (sec) (N) appearance strength (N)Example 3 20 1.5 80 ◯ 115 Example 4 20 2 80 ◯ 120 Example 5 15 3 80 ◯120 Comparative 20 1.5 0 X (Foaming) 60 example 2

As shown in Table 2, evaluations of “external appearance” for Example 3,Example 4, and Example 5 which include pressing of the joint member 3are good (◯). And “joint strength” is 115 to 120 N.

Contrarily, for Comparative example 2 which doesn't include pressing ofthe joint member 3, the evaluation of “external appearance” is not good(x) since foaming occurred in the welded portion. And joint strengthbetween the joint member 3 and the connection section 46 of the outertube 34 is 60 N.

According to the comparative experiment, the case in which thermalwelding is carried out with the joint member 3 pressed resulted inbetter “external appearance” than the case in which the joint member 3is not pressed. Further, in the case when thermal welding is carried outwith the joint member 3 pressed, it is confirmed that the joint member 3and the connection section 46 of the outer tube 34 are firmly joined.Note that, it can be understood that in Comparative example 2, thefoaming occurred in the welded portion resulting in reduction of thelength of the welded portion, thereby reducing joint strength betweenthe joint member 3 and the outer tube 34.

3. Third Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Next, a third embodiment of the needle-equipped outer tube is describedreferring to FIG. 11.

FIG. 11 is an explanatory drawing explaining the third embodiment of theneedle-equipped outer tube.

A needle-equipped outer tube 51 which is the third embodiment has aconfiguration similar to that of the needle-equipped outer tube 31 ofthe second embodiment (see FIG. 8). The needle-equipped outer tube 51 isdifferent from the needle-equipped outer tube 31 in the shape of a jointmember 53 and the shape of a connection section 56 of an outer tube 54.

[Joint Member]

As illustrated in FIG. 11, the joint member 53 is formed in a truncatedconical shape and includes a tubular hole (needle insertion hole) 53 ain which the needle 2 is inserted. The diameter of the tubular hole 53 ais larger than the outer diameter of the needle 2 by about 0.01 to 0.08mm, preferably, by about 0.01 to 0.03 mm. The plane surface of the jointmember 53 having larger diameter is referred to as a distal end surface53 b and the plane surface having smaller diameter is referred to as arear end surface 53 c. The distal end surface 53 b is a press forcereceiving surface which is pressed by the pressing portion 101 a (seeFIG. 11) of the pressing apparatus 101.

As a material of the joint member 53, a resin similar to that used forthe joint member 3 according to the first and second embodiments ispreferably used. Further, it is preferable that the material of thejoint member 53 is substantially transparent so that the inside of thejoint member 53 is visible.

[Outer Tube]

The outer tube 54 includes the outer tube body 15 in which a medicine isfilled and a connection section 56 to which the joint member 53 isjoined. The connection section 56 is configured with a proximal end sideengagement portion 58 which is continued to the end portion 15 b of theouter tube body 15 and a distal end side engagement portion 59 which iscontinued to the proximal end side engagement portion 58.

The proximal end side engagement portion 58 is formed in a truncatedconical shape. The diameter of the proximal end side engagement portion58 gradually decreases toward the distal end side engagement portion 59.Therefore, the proximal end side engagement portion 58 is formed so asthat the cross section perpendicular to the axial direction of the outertube 54 is a near circle.

The distal end side engagement portion 59 is formed in an approximatelycolumn shape. The axis of the proximal end side engagement portion 58and the axis of the distal end side engagement portion 59 are identicalto the axis of the outer tube body 15. Further, the cap 5 (see FIG. 4)engages with the distal end side engagement portion 59.

In the connection section 56, an engagement hole 56 a which runsthroughout the distal end side engagement portion 59 and the proximalend side engagement portion 58 is formed. The engagement hole 56 a isformed in a tapered shape (tapered inner shape) having a circular crosssection of which diameter gradually decreases toward the end portion 15b of the outer tube body 15. The joint member 53 is inserted in theengagement hole 56 a. In this manner, the joint member 53 engages withthe connection section 56 via the tapered shape.

The joint member 53 is formed in a tapered shape (tapered outer shape)so as to engage with the engagement hole 56 a. Further, taper angles ofthe engagement hole 56 a and the joint member 53 are not particularlylimited, though an angle of 1 to 3 degrees is preferable.

Note that, the proximal end side engagement portion 58 of the connectionsection 56 may include the needle stopping portion 21 (see FIG. 6)thereinside. By providing the needle stopping portion 21 inside theproximal end side engagement portion 58, the needle 2 is positionedagainst the joint member 53 and the outer tube 54, and the proximal end2 b of the needle 2 is arranged in the connection section 56. As aresult, the dead volume in the outer tube 54 can be reduced, therebyreducing the amount of medicine remaining in the outer tube 54.

As a material of the outer tube 54 configured with the connectionsection 56 and the outer tube body 15, a resin similar to that used forthe joint member 53 is preferably used. Further, it is preferable thatthe material of the outer tube 54 is substantially transparent so thatthe inside of the outer tube 54 is visible.

Further, the connection section 56 of the outer tube 54 and the jointmember 53 are joined by thermal welding. Therefore, it is preferablethat the material of the outer tube 54 is substantially the same as thematerial of the joint member 53. In this manner, preferable bondabilitybetween the connection section 56 and the joint member 53 can beobtained so that the connection section 56 and the joint member 53 canfirmly be fixed. Further, the welded portion between the connectionsection 56 and the joint member 53 can be made inconspicuous so thataesthetic of the needle-equipped outer tube 51 can be improved.

The needle-equipped outer tube 51 having the configuration as describedabove can be manufactured using either the method for manufacturingdescribed in the first embodiment or the method for manufacturingdescribed in the second embodiment. Consequently, the needle 2 (notshown in the drawing) can be fixed to the outer tube 54 without using anadhesive.

Further, since the thermal welding is carried out with the distal endsurface 53 b of the joint member 53 pressed along the axial direction ofthe outer tube 54 by the pressing apparatus 101, no gap is producedbetween the joint member 53 and the connection section 56 of the outertube 54. Therefore, foaming does not occur in the joint member 53 whenthe joint member 53 is heated. As a result, transparency is provided tothe joint section without deteriorating aesthetic, and at the same time,the joint member 53 and the needle 2 (not shown in the drawing) as wellas the joint member 53 and the connection section 56 of the outer tube54 can tightly be fixed.

4. Fourth Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Next, the fourth embodiment of the needle-equipped outer tube will bedescribed referring to FIG. 12.

FIG. 12 is an explanatory drawing of the fourth embodiment of theneedle-equipped outer tube.

A needle-equipped outer tube 61 which is the fourth embodiment has aconfiguration similar to that of the needle-equipped outer tube 31 ofthe second embodiment (see FIG. 8). The needle-equipped outer tube 61 isdifferent from the needle-equipped outer tube 31 in the shape of a jointmember 63 and the shape of a connection section 66 of an outer tube 64.

[Joint Member]

As illustrated in FIG. 12, the joint member 63 is formed in a truncatedquadrangular pyramid and includes a tubular hole (needle insertion hole)63 a in which the needle 2 is inserted. The diameter of the tubular hole63 a is larger than the outer diameter of the needle 2 by about 0.01 to0.08 mm, preferably, by about 0.01 to 0.03 mm. The plane surface of thejoint member 63 having larger area is referred to as a distal endsurface 63 b, and the plane surface having smaller area is referred toas a rear end surface 63 c. The distal end surface 63 b is a press forcereceiving surface which is pressed by the pressing portion 101 a (seeFIG. 11) of the pressing apparatus 101.

As a material of the joint member 63, a resin similar to that used forthe joint member 3 according to the first and second embodiments ispreferably used. Further, it is preferable that the material of thejoint member 63 is substantially transparent so that the inside of thejoint member 63 is visible.

[Outer Tube]

The outer tube 64 includes the outer tube body 15 in which a medicine isfilled and a connection section 66 to which the joint member 63 isjoined. The connection section 66 is configured with a proximal end sideengagement portion 68 which is continued to the end portion 15 b of theouter tube body 15 and a distal end side engagement portion 69 which iscontinued to the proximal end side engagement portion 68.

The proximal end side engagement portion 68 is formed in a truncatedconical shape. The diameter of the proximal end side engagement portion68 gradually decreases toward the distal end side engagement portion 69.Therefore, the proximal end side engagement portion 68 is formed so asthat the cross section perpendicular to the axial direction of the outertube 64 is a near circle. Note that, the proximal end side engagementportion 68 may include the needle stopping portion 21 (see FIG. 6)thereinside.

The distal end side engagement portion 69 is formed in an approximatelycolumn shape. The axis of the proximal end side engagement portion 68and the axis of the distal end side engagement portion 69 are identicalto the axis of the outer tube body 15. Further, the cap 5 (see FIG. 4)engages with the distal end side engagement portion 69.

In the connection section 66, an engagement hole 66 a which runsthroughout the distal end side engagement portion 69 and the proximalend side engagement portion 68 is formed. The engagement hole 66 a isformed in a tapered shape (tapered inner shape) having a rectangularcross section of which contour gradually decreases toward the endportion 15 b of the outer tube body 15. The joint member 63 is insertedin the engagement hole 66 a. In this manner, the joint member 63 engageswith the connection section 66 via the tapered shape.

The joint member 63 is formed in a tapered shape (tapered outer shape)so as to engage with the engagement hole 66 a. Further, taper angles ofthe engagement hole 66 a and the joint member 63 are not particularlylimited, though an angle of 1 to 3 degrees is preferable.

As a material of the outer tube 54 configured with the connectionsection 66 and the outer tube body 15, a resin similar to that used forthe joint member 63 is preferably used. Note that, it is preferable thatthe material of the outer tube 64 is substantially transparent so thatthe inside of the outer tube 64 is visible. Further, the connectionsection 66 of the outer tube 64 and the joint member 63 are joined bythermal welding. Therefore, it is preferable that the material of theouter tube 64 is substantially the same as the material of the jointmember 63.

The needle-equipped outer tube 61 having the configuration as describedabove can be manufactured using either the method for manufacturingdescribed in the first embodiment or the method for manufacturingdescribed in the second embodiment. As a result, the needle 2 (not shownin the drawing) is fixed to the outer tube 64 without using an adhesive.

Further, since the thermal welding is carried out with the distal endsurface 63 b of the joint member 63 pressed along the axial direction ofthe outer tube 64 by the pressing apparatus 101, no gap is producedbetween the joint member 63 and the connection section 66 of the outertube 64. Therefore, foaming does not occur in the joint member 63 whenthe joint member 63 is heated. As a result, transparency is provided tothe joint section without deteriorating aesthetic, and at the same time,the joint member 63 and the needle 2 (not shown in the drawing) as wellas the joint member 63 and the connection section 66 of the outer tube64 can tightly be fixed.

5. Fifth Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Now, the fifth embodiment of the needle-equipped outer tube will bedescribed referring to FIG. 13. FIG. 13 is an explanatory drawing of thefifth embodiment of the needle-equipped outer tube.

A needle-equipped outer tube 71 which is the fifth embodiment has aconfiguration similar to that of the needle-equipped outer tube 31 ofthe second embodiment (see FIG. 8). The needle-equipped outer tube 71 isdifferent from the needle-equipped outer tube 31 in the shape of a jointmember 73 and the shape of a connection section 76 of an outer tube 74.

[Joint Member]

As illustrated in FIG. 13, the joint member 73 is formed in a polygonalcolumnar shape so as to have a hexagram cross section in a directionperpendicular to the axial direction. The joint member 73 includes atubular hole (needle insertion hole) 73 a in which the needle 2 (notshown in the drawing) is inserted. The diameter of the tubular hole 73 ais larger than the outer diameter of the needle 2 by about 0.01 to 0.08mm, preferably, by about 0.01 to 0.03 mm.

The joint member 73 is formed in a tapered shape of which contourgradually decreases from the end portion toward the other end portionalong the axial direction. The plane surface of the joint member 73 onthe end along the axial direction having larger area is referred to as adistal end surface 73 b, and the plane surface on the other end havingsmaller area is referred to as a rear end surface 73 c. The distal endsurface 73 b is a press force receiving surface which is pressed by thepressing portion 101 a (see FIG. 11) of the pressing apparatus 101.

As a material of the joint member 73, a resin similar to that used forthe joint member 3 according to the first and second embodiments ispreferably used. Further, it is preferable that the material of thejoint member 73 is substantially transparent so that the inside of thejoint member 73 is visible.

[Outer Tube]

The outer tube 74 includes the outer tube body 15 in which a medicine isfilled and the connection section 76 to which the joint member 73 isjoined. The connection section 76 is configured with a proximal end sideengagement portion 78 which is continued to the end portion 15 b of theouter tube body 15 and a distal end side engagement portion 79 which iscontinued to the proximal end side engagement portion 78.

The proximal end side engagement portion 78 is formed in a truncatedconical shape. The diameter of the proximal end side engagement portion78 gradually decreases toward the distal end side engagement portion 79.Therefore, the proximal end side engagement portion 78 is formed so asthat the cross section perpendicular to the axial direction of the outertube 74 is a near circle. Note that, the proximal end side engagementportion 78 may include the needle stopping portion 21 (see FIG. 6)thereinside.

The distal end side engagement portion 79 is formed in an approximatelycolumn shape. The axis of the proximal end side engagement portion 78and the axis of the distal end side engagement portion 79 are identicalto the axis of the outer tube body 15. Further, the cap 5 (see FIG. 4)engages with the distal end side engagement portion 79.

In the connection section 76, an engagement hole 76 a which runsthroughout the distal end side engagement portion 79 and the proximalend side engagement portion 78 is formed. The engagement hole 76 a isformed in a tapered shape (tapered inner shape) having a hexagram crosssection of which contour gradually decreases toward the end portion 15 bof the outer tube body 15. The joint member 73 is inserted in theengagement hole 76 a. In this manner, the joint member 73 engages withthe connection section 76 via the tapered shape.

The joint member 73 is formed in a tapered shape (tapered outer shape)so as to engage with the engagement hole 76 a. Further, taper angles ofthe engagement hole 76 a and the joint member 73 are not particularlylimited, though an angle of 1 to 3 degrees is preferable.

As a material of the outer tube 74 configured with the connectionsection 76 and the outer tube body 15, a resin similar to that used forthe joint member 73 is preferably used. Note that, it is preferable thatthe material of the outer tube 74 is substantially transparent so thatthe inside of the outer tube 74 is visible. Further, the connectionsection 76 of the outer tube 74 and the joint member 73 are joined bythermal welding. Therefore, it is preferable that the material of theouter tube 74 is substantially the same as the material of the jointmember 73.

The needle-equipped outer tube 71 having the configuration as describedabove can be manufactured using either the method for manufacturingdescribed in the first embodiment or the method for manufacturingdescribed in the second embodiment. As a result, the needle 2 (not shownin the drawing) is fixed to the outer tube 74 without using an adhesive.

Further, since the thermal welding is carried out with the distal endsurface 73 b of the joint member 73 pressed along the axial direction ofthe outer tube 74 by the pressing apparatus 101, no gap is producedbetween the joint member 73 and the connection section 76 of the outertube 74. Therefore, foaming does not occur in the joint member 73 whenthe joint member 73 is heated. As a result, transparency is provided tothe joint section without deteriorating aesthetic, and at the same time,the joint member 73 and the needle 2 (not shown in the drawing) as wellas the joint member 73 and the connection section 76 of the outer tube74 can tightly be fixed.

6. Sixth Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Next, the sixth embodiment of the needle-equipped outer tube will bedescribed referring to FIG. 14.

FIG. 14 is an explanatory drawing of the sixth embodiment of theneedle-equipped outer tube.

A needle-equipped outer tube 81 which is the sixth embodiment has aconfiguration similar to that of the needle-equipped outer tube 31 ofthe second embodiment (see FIG. 8). The needle-equipped outer tube 81 isdifferent from the needle-equipped outer tube 31 in the shape of a jointmember 83 and the shape of a connection section 86 of an outer tube 84.

[Joint Member]

As illustrated in FIG. 14, the joint member 83 is formed in anapproximately cylindrical shape having a tubular hole (needle insertionhole) 83 a in which the needle 2 is inserted. The diameter of thetubular hole 83 a is larger than the outer diameter of the needle 2 (notshown in the drawing) by about 0.01 to 0.08 mm, preferably, by about0.01 to 0.03 mm.

The joint member 83 is configured with a distal end side tubular portion84 and a rear end side tubular portion 85 having an outer diametersmaller than that of the distal end side tubular portion 84. The distalend side tubular portion 84 is formed in a cylindrical shape having auniform outer diameter.

On the end portion, opposite to the rear end side tubular portion 85, ofthe distal end side tubular portion 84, a distal end surface 84 a isformed. The distal end surface 84 a is a press force receiving surfacewhich is pressed by the pressing portion 101 a of the pressing apparatus101 which will be described below. On the end portion, opposite to therear end side tubular portion 84, of the distal end side tubular portion84, a contact surface 84 b is formed. The contact surface 84 b makescontact with the connection section 86 of the outer tube 84. Further,the cap 5 (see FIG. 4) engages with the distal end side engagementportion 84.

The rear end side tubular portion 85 is formed in a truncated conicalshape. The diameter of the rear end side tubular portion 85 graduallydecreases toward the end portion opposite to the distal end side tubularportion 84. Further, on the end portion, opposite to the distal end sidetubular portion 84, of the rear end side tubular portion 85, a rear endsurface 85 a is formed.

As a material of the joint member 83, a resin similar to that used forthe joint member 3 according to the first and second embodiments ispreferably used. Further, it is preferable that the material of thejoint member 83 is substantially transparent so that the inside of thejoint member 83 is visible.

[Outer Tube]

The outer tube 84 includes the outer tube body 15 in which a medicine isfilled and a connection section 86 to which the joint member 83 isjoined. The connection section 86 is continued to the end portion 15 bof the outer tube body 15.

The connection section 86 is formed, similarly to the tapered engagementportion 48 (see FIG. 8) of the connection section 46 according to thesecond embodiment, in a truncated conical shape. The diameter of theconnection section 86 gradually decreases toward the distal end sideengagement portion 19.

The connection section 86 includes an engagement hole 86 a. Theengagement hole 86 a is formed in a tapered shape (tapered inner shape)in which the diameter gradually decreases toward the end portion 15 b ofthe outer tube body 15. The rear end side tubular portion 85 of thejoint member 83 is inserted in the engagement hole 86 a. In this manner,the rear end side tubular portion 85 of the joint member 83 engages withthe connection section 86 via the tapered shape. Note that, theconnection section 86 may include the needle stopping portion 21 (seeFIG. 6) thereinside.

The rear end side tubular portion 85 of the joint member 83 is formed ina tapered shape (tapered outer shape) so as to engage with theengagement hole 86 a. Further, taper angles of the engagement hole 86 aand the rear end side tubular portion 85 are not particularly limited,though an angle of 1 to 3 degrees is preferable.

As a material of the outer tube 84 configured with the connectionsection 86 and the outer tube body 15, a resin similar to that used forthe joint member 83 is preferably used. Note that, it is preferable thatthe material of the outer tube 84 is substantially transparent so thatthe inside of the outer tube 84 is visible. Further, the connectionsection 86 of the outer tube 84 and the rear end side tubular portion 85of the joint member 83 are joined by thermal welding. Therefore, it ispreferable that the material of the outer tube 84 is substantially thesame as the material of the joint member 83.

The needle-equipped outer tube 81 having the configuration as describedabove can be manufactured using either the method for manufacturingdescribed in the first embodiment or the method for manufacturingdescribed in the second embodiment. As a result, the needle 2 (not shownin the drawing) is fixed to the outer tube 84 without using an adhesive.

Further, since the thermal welding is carried out with the distal endsurface 84 a of the joint member 83 pressed along the axial direction ofthe outer tube 84 by the pressing apparatus 101, no gap is producedbetween the rear end side tubular portion 85 of the joint member 83 andthe connection section 86 of the outer tube 84. Therefore, foaming doesnot occur in the rear end side tubular portion 85 when the rear end sidetubular portion 85 of the joint member 83 is heated. As a result,transparency is provided to the joint section without deterioratingaesthetic, and at the same time, the joint member 83 and the needle 2(not shown in the drawing) as well as the rear end side tubular portion85 of the joint member 83 and the connection section 86 of the outertube 84 can tightly be fixed.

7. Seventh Embodiment of the Needle-Equipped Outer Tube

<Configuration of a Needle-Equipped Outer Tube>

Next, the seventh embodiment of the needle-equipped outer tube will bedescribed referring to FIG. 15.

FIG. 15 is an explanatory drawing of the seventh embodiment of theneedle-equipped outer tube.

A needle-equipped outer tube 91 which is the seventh embodiment has aconfiguration similar to that of the needle-equipped outer tube 51 ofthe third embodiment (see FIG. 11). The needle-equipped outer tube 91 isdifferent from the needle-equipped outer tube 51, solely, in the shapeof a joint member 93.

As illustrated in FIG. 15, the joint member 93 of the needle-equippedouter tube 91 is formed, similarly to the joint member 53 according tothe third embodiment, in a truncated conical shape. The joint member 93includes a tubular hole 93 a, a distal end surface 93 b, a rear endsurface 93 c, and an outer circumferential surface 93 d.

Further, substantially same transparent materials are used for materialsof the joint member 93 and the outer tube 54.

Roughening process is applied to the outer circumferential surface 93 dof the joint member 93.

As the method of roughening process applied to the outer circumferentialsurface of the joint member 93, for example, a method of transferringthe roughness provided on a mold for forming the joint member 93 may beused. Further, blasting may be applied after forming the joint member 93having a smooth outer circumferential surface. Further, the roughness ofthe outer circumferential surface of the joint member 93, afterroughening process is applied, is preferably, for example, Ra 0.1 to 3.Further, satin process or embossing process may be applied to the outercircumferential surface 93 d of the joint member 93.

The needle-equipped outer tube 91 having the configuration as describedabove can be manufactured using either the method for manufacturingdescribed in the first embodiment or the method for manufacturingdescribed in the second embodiment. Consequently, the needle 2 (notshown in the drawing) can be fixed to the outer tube 54 without using anadhesive.

Further, since the thermal welding is carried out with the distal endsurface 93 a of the joint member 93 pressed along the axial direction ofthe outer tube 54 by the pressing apparatus 101, no gap is producedbetween the joint member 93 and the connection section 56 of the outertube 54. Therefore, foaming does not occur in the joint member 93 whenthe joint member 93 is heated. As a result, transparency is provided tothe joint section without deteriorating aesthetic, and at the same time,the joint member 93 and the needle 2 (not shown in the drawing) as wellas the joint member 93 and the connection section 56 of the outer tube54 can tightly be fixed.

Further, as for the joint section between the joint member 93 and theconnection section 56, the welded portion becomes transparent and theportion which is not welded becomes nontransparent. Therefore, it caneasily be recognized whether the welded state between the joint member93 and the connection section 56 is good.

In the embodiment, roughening process is applied to the outercircumferential surface of the joint member 93. However, rougheningprocess can be applied to the inner circumferential surface of theconnection section 53 to manufacture the needle-equipped outer tube ofthe present invention. Further, the roughening process applied in theembodiment can be applied in the first, second, and fourth to sixthembodiments described above.

The present invention is not limited to the embodiments described aboveand illustrated in the drawings. Various modifications can be madewithout departing from the spirit and the scope of the present inventiondescribed in the claims.

For example, in the first and second embodiments described above, highfrequency welding and laser welding are applied as specific examples ofthermal welding, though ultrasonic welding can be applied as the thermalwelding according to embodiments of the present invention.

Further, the outer tube 4 of the first embodiment described above can bereplaced with the outer tube 34 of the second embodiment describedabove. Similarly, the outer tube 34 of the second embodiment can bereplaced with the outer tube 4 of the first embodiment.

Further, in the first embodiment described above, the cross section ofthe tapered engagement portion 18 of the connection section 16 is formedin an approximate cross-shape, and in the second to seventh embodimentsdescribed above, the cross section of the tapered engagement portion ofthe connection section is formed in a near circle (approximatelycylindrical shape). However, the cross section of the connection sectionaccording to the present invention may be a polygon such as a triangleand a rectangle, or may be other shapes such as an ellipse and a halfcircle.

Further, in the first to seventh embodiments described above, the jointmember is configured to engage with the connection section via thetapered shape. However, in the method for manufacturing theneedle-equipped outer tube of the present invention, it is not limitedto the engagement via the tapered shape as long as the joint member andthe connection section engage with each other during thermal welding.Note that, it is effective to engage the joint member and the connectionsection via the tapered shape, in that a gap (clearance) between thejoint member and the connection section can be eliminated or made small,thereby preventing foaming during the thermal welding.

Further, in the first to seventh embodiments described above, the shapeof the joint member is formed in a truncated conical shape, a truncatedquadrangular pyramid, or a polygonal columnar shape (hexagram). However,the shape of the joint member according to embodiments of the presentinvention may suitably be modified as long as the shape allows joiningto the connection section.

What is claimed is:
 1. A needle-equipped outer tube comprising: aneedle; a transparent joint member that supports the needle, the needlebeing insert molded or thermally welded to the transparent joint member;and a transparent outer tube including a connection section, wherein thetransparent joint member is thermally welded to the connection sectionof the transparent outer tube at a thermally welded portion such that auniform and transparent boundary surface is formed between thetransparent joint member and the connection section without foaming atthe thermally welded portion.
 2. The needle-equipped outer tubeaccording to claim 1, wherein a connection between the transparent jointmember and the connection section is a connection formed by thermallywelding the transparent joint member to the connection section while thetransparent joint member is pressed against the connection section in anaxial direction of the transparent outer tube.
 3. The needle-equippedouter tube according to claim 2, wherein the transparent joint memberincludes a press force receiving surface from which the needleprotrudes, the press force receiving surface being configured to bepressed during said thermal welding.
 4. The needle-equipped outer tubeaccording to claim 1, wherein a first end portion of the needle isarranged in the connection section of the transparent outer tube.
 5. Theneedle-equipped outer tube according to claim 1, wherein a material ofwhich the joint member is formed is substantially the same as a materialof which the outer tube is formed.
 6. The needle-equipped outer tubeaccording to claim 5, wherein the material of which the joint member isformed is the same as the material of which the outer tube is formed. 7.The needle-equipped outer tube according to claim 6, wherein the jointmember and the outer tube each comprise a cyclic polyolefin material.